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Seltorexant for Depression
Study Summary
This trial is testing whether seltorexant can improve depressive symptoms in people with MDD who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI. The trial will also assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in people with MDD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I've tried 1-2 antidepressants for my current depression episode without enough improvement.I have a significant sleep disorder, but not insomnia.I've been taking a specific antidepressant without issues for 6 weeks to 18 months.You have had a serious problem with using drugs or alcohol in the past 6 months.Your body mass index (BMI) falls within the range of 18 to 40 kilograms per square meter (kg/m^2).I've been taking a specific antidepressant without issues for 6 weeks to 18 months.I do not have severe kidney issues or uncontrolled health problems including diabetes.I have been diagnosed with depression without psychosis, first noticed before I was 60, and it has lasted no more than 24 months.My recent health checks, including heart tests, show I am medically stable.My recent health checks, including heart tests, show I am medically stable.Your weight is within a certain range based on your height, known as Body Mass Index (BMI).You have a history or current diagnosis of certain mental health conditions like psychosis, bipolar disorder, intellectual disability, autism, borderline personality disorder, or somatoform disorders.I've tried 1-2 antidepressants without enough improvement in my current depression episode.I have been diagnosed with depression without psychosis, first noticed before I was 60, and it has lasted no more than 24 months.I have depression that hasn't improved after trying 2 or more treatments.
- Group 1: Seltorexant
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the goals that we hope to achieve with this research?
"The main goal of this clinical trial is to measure the effect of the treatment on participants' sexual function, as measured by the Arizona Sexual Experiences Scale (ASEX) score. The trial will also track changes in participants' depression symptoms (as measured by the MADRS-6 scale), sleep quality (as measured by the PROMIS-SD), and overall symptoms of depression (as measured by the MADRS-WOSI scale)."
Does this clinical research involve seniors who are 75 years old or older?
"The age requirements to participate in this clinical trial are 18 to 74. However, if you are outside of this age range, there may be other trials more suited for you as 202 trials exist for those under 18 and 986 for those over 65."
To whom does this experiment extend an invitation?
"This trial is looking for 550 patients that have involutional psychosis and are between 18 and 74 years old. Most importantly, potential participants must meet the following requirements: Be diagnosed with major depressive disorder (MDD) without any psychotic features, according to the Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5), Have a current depressive episode that is shorter than 24 months, Be tolerating and responding well to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms, Have a body mass index (BMI) between"
How many total people are taking part in this clinical research project?
"In order for this clinical trial to move forward, 550 people who fit the pre-determined inclusion criteria need to sign-up. Those interested can participation from Haidar Almhana Nieding in Avon Lake, Ohio and American Medical Research, Inc. in Oak Brook, Illinois."
Does Seltorexant have a history of successful clinical trials?
"Universitaetsklinikum der RWTH Aachen first began to study seltorexant in 2020. To date, there have been 18253 completed trials and 6 that are still recruiting patients. The majority of these remaining trials are taking place in Avon Lake, Ohio."
Has Seltorexant received FDA approval for use?
"Seltorexant is a Phase 3 trial drug, meaning that while there is some efficacy data, there is mostly safety data. Our team rates it a 3."
Are people still being recruited for this clinical trial?
"Yes, the information available on clinicaltrials.gov indicates that this particular clinical trial is currently recruiting patients. This trial was first posted on September 16th, 2020, and was last updated on October 12th, 2020. The study is looking for 550 participants across 45 different locations."
Has this clinical trial been attempted before?
"Seltorexant was first studied in 2020 by Janssen Research & Development, LLC. The Phase 1 clinical trial involved 64 patients. Following the success of the first study, Seltorexant received approval as a Phase 1 drug. Presently, there are 6 active trials being conducted in 132 cities and 28 countries."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
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Most responsive sites:
- Synexus Clinical Research US, Inc: < 48 hours
Average response time
- < 2 Days
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